BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DETERMINE HIV-1/2 AG/AB COMBO 25T

    MDR report key: 21612383 · Received March 14, 2025

    Report

    Report Number
    1221359-2025-00100
    Event Type
    Malfunction
    Date Received
    March 14, 2025
    Date of Event
    February 17, 2025
    Report Date
    March 14, 2025
    Manufacturer
    ABBOTT DIAGNOSTICS SCARBOROUGH, INC.
    Product Code
    MZF
    UDI-DI
    00811877011101
    PMA / PMN Number
    BP120037
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ABBOTT MEDICAL AFFAIRS WAS CONSULTED AND INDICATED THAT DUE TO THE VERY LIMITED INFORMATION REGARDING PATIENT'S CONDITIONS, CAUSE OF DEATH AND SEQUENCE OF EVENTS, THERE IS NO CLEAR REASON TO ATTRIBUTE THE CONFLICTING RESULT WITH THE DETERMINE HIV 1/2 AG/AB COMBO TO A CARDIAC ARREST AND/OR TO THE DEATH. TESTING WAS PERFORMED AT ABBOTT DIAGNOSTICS SCARBOROUGH, INC. THE DETERMINE HIV-1/2 AG/AB COMBO RETAIN KIT 0000927862 WAS TESTED FOR FUNCTIONALITY WITH 20 WHOLE BLOOD (WB) AND 20 NORMAL HUMAN SERUM (NHS) SAMPLES FROM AN INTERNAL QC SPECIFICITY PANEL, AND 1 EACH OF NEGATIVE WB AND NHS DILUENT, HIV-1, HIV-2, AND P24. ALL POSITIVE CONTROLS WERE MADE BY SPIKING THE NEGATIVE DILUENT. ALL TESTS WERE VALID AND PERFORMED AS EXPECTED. ADDITIONALLY, THE MANUFACTURING RECORDS AND QUALITY CONTROL RELEASE TESTING WAS REVIEWED FOR TEST KIT PART NUMBER 7D2648 / LOT 0000927862 AND DEVICE PART NUMBER 10732998 / LOT 912601. THE LOT MET THE REQUIRED RELEASE SPECIFICATIONS. A REVIEW OF THE COMPLAINTS REPORTED AS FALSE POSITIVE AND FALSE NEGATIVE PATIENT RESULTS (CONFIRMED AND UNCONFIRMED, CONFLICTING RESULTS) RELATED TO KIT LOT 0000927862 SHOWED THAT THE COMPLAINT RATE IS (B)(4), RESPECTIVELY. ABBOTT DIAGNOSTICS SCARBOROUGH, INC. WAS UNABLE TO DETERMINE THE EXACT ROOT CAUSE OF THE CONFLICTING RESULTS; HOWEVER, IT COULD HAVE POSSIBLY BEEN RELATED TO THE SPECIFIC PATIENT SAMPLE AND/OR THE CUSTOMER'S POTENTIAL USE OF A K2 OR K3 EDTA TUBE FOR PLASMA SAMPLE COLLECTION.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED TWO (2) INSTANCES OF CONFLICTING RESULTS WITH DETERMINE HIV-1/2 AG/AB COMBO TEST ON (B)(6) 2025 USING SERUM AND WHOLE BLOOD SAMPLES. THIS REPORT ADDRESSES TEST ONE (1) OF TWO (2). THE BLOOD SAMPLE WAS TAKEN VIA VENIPUNCTURE AND COLLECTED IN A PINK EDTA TUBE. THE FIRST AND SECOND TEST GENERATED POSITIVE RESULTS USING PLASMA SAMPLES. THE THIRD TEST GENERATED A NEGATIVE RESULT USING A WHOLE BLOOD SAMPLE. CONFIRMATORY TESTING WAS PERFORMED, AND THE RESULTS WERE NOT PROVIDED. THE CUSTOMER CONFIRMED THERE WAS NO NEGATIVE IMPACT TO PATIENT CARE, NO TREATMENT WAS GIVEN BASED ON THE DISCREPANT RESULT AND THE EVENT DID NOT LEAD TO DELAYED OR MISSED TREATMENT OR MEDICATION. THE CUSTOMER REPORTED THAT PATIENT HAD MEDICAL HISTORY OF CARDIAC ARREST AND UNDERTOOK HIV ½ AB/AG TEST, HEPATITIS B SURFACE ANTIGEN TEST AND HEPATITIS C ANTIBODY TEST AND PASSED AWAY. ALTHOUGH REQUESTED, THE CUSTOMER INDICATED THAT NO ADDITIONAL INFORMATION INCLUDING HEALTH ISSUE OF PATIENT OR CAUSE OF DEATH WILL BE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    690175 DETERMINE HIV-1/2 AG/AB COMBO 25T TEST, HIV DETECTION MZF ABBOTT DIAGNOSTICS SCARBOROUGH, INC. 0000927862 00811877011101

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Male